Study Stopped
Administratively Complete.
SB-715992 in Treating Patients With Metastatic or Unresectable Solid Tumors or Hodgkin's or Non-Hodgkin's Lymphoma
A Phase I, Open-Label, Dose-Escalation Study of SB-715992 Administered Days 1-3 of a 21-Day Cycle in Patients With Solid Tumors
4 other identifiers
interventional
31
1 country
1
Brief Summary
This phase I trial is studying the side effects and best dose of SB-715992 in treating patients with metastatic or unresectable solid tumors or Hodgkin's or non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as SB-715992, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 7, 2005
CompletedFirst Posted
Study publicly available on registry
January 10, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedJanuary 14, 2013
January 1, 2013
5.3 years
January 7, 2005
January 11, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum tolerated dose (MTD), based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
Up to 21 days
Secondary Outcomes (4)
Clinical response (complete response [CR], partial response [PR], and response duration) based on the Response Evaluation Criteria in Solid Tumors (RECIST)
Up to 6 years
Plasma ispinesib concentration levels
Up to day 24
Pre- and post-treatment intra-tumoral drug levels (from tumor-accessible, consenting patients only)
Up to day 3
Cluster of differentiation (CD)34+ stem cell levels
Pre-treatment
Study Arms (1)
Treatment (ispinesib)
EXPERIMENTALPatients receive SB-715992 IV over 1 hour on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SB-715992 until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 10 additional patients are treated at the MTD.
Interventions
Correlative studies
Eligibility Criteria
You may qualify if:
- Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; patients with solid hematologic malignancies (Hodgkin's and non-Hodgkin's lymphomas) may be included as long as a bone marrow has been performed within 6 weeks of enrollment
- Prior chemotherapy is allowed; patients may not have received chemotherapy for 4 weeks prior to the initiation of study treatment and must have full recovery from the acute effects of any prior chemotherapy; patients must not have had nitrosoureas or mitomycin C for 6 weeks prior to initiation of study treatment
- Prior radiation therapy is allowed; patients must have completed radiation at least 4 weeks prior to initiation of study treatment; patients who have received prior radiation to 50% or more of their total marrow volume will be excluded
- Prior treatment with EGFR inhibitors is allowed; prior experimental therapies (non FDA-approved agents) and immunotherapies are allowed; patients may not have received these therapies for 4 weeks prior to the initiation of study treatment and must have a full recovery from the acute effects of these therapies
- ECOG performance status =\< 2 (Karnofsky \>= 60%)
- Life expectancy of \> 12 weeks
- Absolute neutrophil count \>= 1,500/uL
- Platelets \>= 100,000/uL
- Total bilirubin =\< normal institutional limits
- AST(SGOT)/ALT(SGPT) =\< 2.5 X institutional upper limit of normal
- Creatinine =\< 1.5 X institutional upper limit of normal OR creatinine clearance (calculated) or measured clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
- The effects of SB-715992 on the developing human fetus are unknown; for this reason and because mitotic inhibitors are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and the willingness to sign a written informed consent document
You may not qualify if:
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from acute AEs due to agents administered more than 4 weeks earlier
- Patients may not have received any other investigational agents within 28 days of study entry
- Patients may not receive any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) while on this study except for medications that are prescribed for supportive care but potentially may have anticancer effect (i.e. megestrol acetate, bisphosphonates); these medications must have been started 1 month prior to enrollment on study; in addition, men receiving treatment for prostate cancer will be maintained at castrate levels of testosterone by continuation of luteinizing- releasing hormone agonists
- Prohibited medications: SB-715992 is a moderate to significant in vitro inhibitor of CYP3A4; the following lists of medications/substances are moderate to significant inhibitors/inducers of CYP3A4 that, if administered concomitantly with SB-715992, may alter study drug exposure; the use of these medications/substances within 14 days (\>= 6 months for amiodarone) prior to the administration of the first dose of SB-715992 through discontinuation from the study is prohibited;
- Inhibitors of CYP3A4
- Antibiotics: clarithromycin, erythromycin, troleandomycin
- Antifungals: itraconazole, ketoconazole, fluconazole (doses \> 200 mg/day), voriconazole
- Antidepressants: nefazodone, fluovoxamine
- Calcium channel blockers: verapamil, diltiazem
- Bitter Orange
- Miscellaneous: amiodarone\*, grapefruit juice\*\*; \*use of amiodarone within 6 months prior to the administration of the first dose of SB-715992 is prohibited; \*\* use of grapefruit juice within 7 days prior to administration of the first dose of SB-715992 is prohibited
- Inducers of CYP3A4
- Anticonvulsants: phenytoin, carbamazepine, phenobarbital
- Antibiotics: rifampin, rifabutin, rifapentine
- Miscellaneous: St. John's wort, modafinil, oxcarbazepine
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia LoRusso
Barbara Ann Karmanos Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2005
First Posted
January 10, 2005
Study Start
November 1, 2004
Primary Completion
February 1, 2010
Last Updated
January 14, 2013
Record last verified: 2013-01